Multimodal Analysis of Endomyocardial Biopsies

January 15, 2026 updated by: Lars Michel, University Hospital, Essen

The goal of this observational study is to pursue a multimodal approach to identify the molecular signatures and immune signalling molecules of various myocardial diseases and thereby contribute to improving diagnosis and therapy.

The main aim is:

-Identification of molecular profiles (e.g., proteome, lipidome, metabolome) and immune signalling profiles that are specifically associated with different myocardial diseases and the post-heart transplantation course.

Participants already receiving an endomyocardial biopsy as part of their regular medical care will be enrolled. An additional biopsy sample will be taken for the above mentioned research.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The proposed study aims to pursue a multimodal approach to identify the molecular signatures and immune signalling profiles of various myocardial diseases and thereby contribute to improving diagnosis and therapy. In the context of a clinically indicated endomyocardial biopsy (EMB), an additional EMB will be performed. This sample will be further analyzed using, among other methods, multi-omics, immune signalling analysis and nuclear cardiology analyses. These analyses are intended to enable the identification of genetic mutations, inflammatory gene expression patterns, immune signalling and protein alterations in myocardial diseases such as cardiomyopathies, myocarditis, and cardiac amyloidosis. Furthermore, the results will be correlated with established clinical parameters and biomarkers in order to identify novel diagnostic markers.

Study Type

Observational

Enrollment (Estimated)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Recruiting
        • Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients receiving an endomyocardial biopsy after routine clinical indication will be enrolled. The identification of molecular profiles from the obtained endomyocardial biopsies (EMBs) represents an exploratory research approach that does not allow for an exact sample size calculation. Considering the heterogeneity of the collected EMBs, and particularly the fact that EMBs are often performed for the differential diagnosis of various rare myocardial diseases, an adequately large study population is necessary to capture rare phenotypes. The planned cohort will include 40 patients each from the main groups: unclear cardiomyopathy, suspected (ICI-)myocarditis, suspected cardiac storage disease, and post-heart transplantation surveillance. Thus, a total of 160 EMBs are targeted for multi-omics analysis.The secondary endpoint of the study allows for a sample size estimation of 56 EMBs for the subgroup of cardiac amyloidosis (calculation according to the full proposal).

Description

Inclusion Criteria:

  • Patients aged >18 years with a clinical indication for endomyocardial biopsy.
  • Patients capable of providing informed consent who have signed the consent form for participation in the study.

Exclusion Criteria:

  • Patients without a clinical indication for endomyocardial biopsy (EMB).
  • Pregnant individuals.
  • Patients incapable of providing informed consent.
  • Women of childbearing potential who are not using adequate contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing endomyocardial biopsy following clinical indication
All patients with a clinical indication for EMB without regard to certain disease types. Typically these patients are after heart transplantation, amyloidosi or with a cardiomyopathy, including dilated-, hypertrophic- or inflammatory cardiomyopathy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatial molecular profiles and immune signalling in all included patients
Time Frame: Baseline, up to 1 year
Identification of spatial molecular profiles (e.g., proteomic, lipidomic, and metabolomic signatures) and immune signalling pathways specifically associated with various myocardial diseases and post-heart transplantation outcomes.
Baseline, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracer-Uptakes in cardiac amyloidosis.
Time Frame: Baseline, up to 1 year.
Ex vivo analysis of tracer uptake in human endomyocardial biopsy samples from patients with cardiac amyloidosis.
Baseline, up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Investigators

  • Principal Investigator: Lars Michel, PD Dr. med., Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WHGZ-EMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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